Documents have several important purposes in a clinical trial:

  • To demonstrate compliance with all applicable regulatory requirements
  • To help in the successful management of the study and to keep all informed
  • To confirm the validity of the conduct of the clinical investigation and the integrity of the data collected

The documents used can include:

Case report form (CRF):  A case report form is a form or questionnaire that researchers use to collect patient data (information) for research trials.

Standard operating procedure (SOP):  This is a set of instructions created by an organisation to help clearly outline step-by-step routine actions for staff to follow.  For this trial it means that the health professionals will be able to follow clear guidelines when working through the different stages of the trial.